BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE SUTURE-MEDIATED CLOSURE DEVICE

    MDR report key: 9877629 · Received March 25, 2020

    Report

    Report Number
    9877629
    Event Type
    Malfunction
    Date Received
    March 25, 2020
    Date of Event
    February 27, 2020
    Report Date
    March 10, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INTERVENTIONAL RADIOLOGY TEAM MEMBERS REPORTED ON RECENT CASES OF THE PERCLOSE PROGLIDES NOT WORKING. THEY REPORTED IT HAS BEEN WITH MORE THAN ONE PROVIDER, THAT THIS HAS BEEN GOING ON FOR A COUPLE OF MONTHS, BUT THEY NEGLECTED TO WRITE UP EACH EVENT OF PROGLIDE FAILURE. THE ACTUAL INVOLVED DEVICES WERE NOT SAVED. NO PATIENTS WERE INJURED, BUT ADDITIONAL PROGLIDES WERE NECESSARY TO CLOSE THE ARTERIOTOMIES RESULTING IN ADDITIONAL COSTS. LOT NUMBERS WITH FAILURES ARE: REF # 12673-03/ LOT # 9081244 - WE HAD 5 OF ONE BOX FAIL. TWO REMAINING WERE REMOVED FROM USE. LOT # 9112241, WE HAD 3 FAIL FOR DR. 1. REMOVED REMAINING ONE FROM SHELF. LOT # 9121941 - 1 FAILED FOR DR. 2. HE SAID NO CALCIUM OR OTHER REASON IT SHOULD HAVE FAILED. THE 2ND PROGLIDE DID WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341531 PERCLOSE PROGLIDE SUTURE-MEDIATED CLOSURE DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR 12673-03 9081244

    Patients

    Seq Age Sex Outcome Treatment
    1